Micro-physiological circadian platform for safety and efficacy assessment of drugs and cosmetics

Project Information

mP-CSE

Grant agreement ID: 827858

DOI

10.3030/827858

Project closed

EC signature date 23 July 2018

Start date 1 August 2018

End date 30 November 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

TISSUE DYNAMICS LTD
Israel

Periodic Reporting for period 1 - mP-CSE (Micro-physiological circadian platform for safety and efficacy assessment of drugs and cosmetics)

Reporting period: 2018-08-01 to 2018-11-30

Summary of the context and overall objectives of the project

Novel pharmaceutical compounds are tested for safety using in vitro and animal models before being approved for human clinical studies. These assessments have little predictive value since 90% of drug failures occur during clinical studies and 10% take place after they reach the market, resulting in €1.73B annual costs lost due to marketing and legal expenses. This high failure rate results in overpriced successful drugs.
Cosmetics approval also requires a safety assessment. Since 2013 the EU has banned animal testing for cosmetic products, pushing the demand for alternative testing methods.
Tissue Dynamics has developed mP-CSE, an innovative Organ on Chip (OOC) that replaces animal models in safety and efficacy studies for drug and cosmetics development, saving time and resources. Our award-winning technology uses real-time sensing of metabolic function to detect the effect of drug-induced physiological stress in multiple organs.
mP-CSE has reached TRL 7 and is protected by two patents and a provisional application. We have produced a proof of concept prototype and demonstrated its performance in safety and efficacy assessments. The last development steps will be achieved through mP-CSE project by defining a production prototype, scaling up our industrial capabilities and fulfilling the regulatory requirements to guarantee its successful market deployment.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

1. We have developed our strategy to validate mP-CSE circadian rhythm capabilities, defined mP-CSE manufacturing process, identified key manufacturing partners, validated our industrialisation plan and identified potential technical risks.
2. We have conducted an in-depth analysis on the OOC market, assessed mP-CSE regulatory requirements, validated our commercialisation strategy and updated our dissemination plan. Additionally, we have assessed our IP strategy, confirmed our FTO and identified potential commercial risks.
3. We have defined our funding needs and forecasted mP-CSE financial projections up to 2025. We have also assessed our corporate plan.
4. We have summarised the results of the Feasibility Study in an updated business plan.
The outcome of this Feasibility Study is the decision to continue with the project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

mP-CSE will provide pharmaceutical and cosmetics companies with an effective alternative to animal models for safety and efficacy assessment, accelerating product development while reducing its costs. By replacing animal studies, mP-CSE will also prevent the sacrifice of thousands of animals.

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